From GAWDAwiki
|
||||||||||||||||||||||||||||||||||||||||||||
| Home | Headlines | Airgas South Recalls Cylinders | ||||||||||||||||||||||||||||||||||||||||||||
HeadlinesAirgas South Recalls Cylinders- 7/26/2010Airgas South, Inc. announced an expanded voluntary recall of medical gas products filled at its Chattanooga, TN, facility. The recall is being initiated as a precautionary measure because these products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs) . These practices help assure that drug products meet required quality standards for quality, purity and potency. The potential for serious medical events is remote and other than one initial complaint concerning a contaminated cylinder which triggered the initial recall, Airgas South is not aware of any other confirmed events involving cylinder contamination. The company has no reason to believe that other contaminated cylinders will be found. The recall involves high-pressure medical cylinders containing oxygen, nitrogen, air, nitrous oxide, carbon dioxide, and drug mixtures with expiration dates of July 13, 2010 through July 13, 2015; portable Walk-O2-Bout oxygen cylinders with expiration dates of July 13, 2010 through July 13, 2012, and liquid cylinders (VGL) containing oxygen, nitrogen, carbon dioxide, and nitrous oxide with expiration dates of July 13, 2010 through July 13, 2011. The recall affects customers located in Tennessee, Alabama, and Georgia. After an initial completed recall, further investigation at the Chattanooga facility identified cGMP issues and led to the decision to voluntarily recall additional products as a precaution. As an additional precaution, the Chattanooga facility has ceased medical filling operations until the investigation is complete and the root causes of the issues identified have been resolved. Airgas South’s expanded recall notice asks customers who locate any cylinders within the groups and with the expiration dates affected by the recall to clearly tag and quarantine those cylinders, and contact their local Airgas South representative. Questions concerning the recall may also be directed to Gregory P. Barnett, Safety Director, Airgas South at (770) 590-6036. 
|
||||||||||||||||||||||||||||||||||||||||||||
